Non-Small Cell Lung CancerPhase 1NCT04449874
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
A Phase 1 study testing GDC-6036, Atezolizumab and Cetuximab in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by Genentech, Inc. at 63 sites in 17 countries.
Trial summary
This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors
- What is being tested?
- GDC-6036, Atezolizumab and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 63 sitesin 17 countries
- Study dates
- 29 Jul 2020to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
- Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
- Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.
Who cannot join
- Active brain metastases.
- Malabsorption or other condition that interferes with enteral absorption.
- Clinically significant cardiovascular dysfunction or liver disease.
Trial locations and contacts
63 sites in 17 countries.
63 sites in 17 countries
United States9 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
UCSD Moores Cancer Center
La Jolla, California, 92093
Yale Cancer Center
New Haven, Connecticut, 06511
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center UCI
Orange, California, 92868
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
Brazil7 sites
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, 30150-221
Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, 95070-561
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre, Pará, 90035-903
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto Nacional de Câncer
Rio de Janeiro, 20230-130
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, 15090-000
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, 28050
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Clinico Universitario de Valencia
Valencia, 46010
Italy5 sites
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, Emilia-Romagna, 47014
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089
Australia4 sites
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000
Alfred Health
Melbourne, Victoria, 3004
Slade Health Inward goods
Mount Kuring-Gai, New South Wales, 2080
Linear Clinical Research Limited
Nedlands, Western Australia, 6009
Netherlands4 sites
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Maastricht University Medical Center
Maastricht, 6229 HX
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
South Korea4 sites
Seoul National University Bundang Hospital
Seongnam-si, 13605
Seoul National University Hospital
Seoul, 03080
Asan Medical Center - PPDS
Seoul, 05505
Samsung Medical Center - PPDS
Seoul, 06351
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2GW
Velindre Cancer Centre
Cardiff, CF14 2TL
NIHR UCLH Clinical Research Facility
London, W1T 7HA
The Christie NHS Foundation Trust
Manchester, M20 4BX
Belgium3 sites
UZ Antwerpen
Edegem, 2650
CHU de Liège
Liège, 4000
AZ St Maarten Campus Leopoldstr
Mechelen, 2800
Canada3 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
New Zealand3 sites
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023
Auckland City Hospital
Auckland
New Zealand Clinical Research - Christchurch
Christchurch
Israel2 sites
Rambam Medical Center
Haifa, 3109601
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
Norway2 sites
Haukeland University Hospital
Bergen, 5020
Oslo university hospital Radiumhospitalet
Oslo, 0424
Poland2 sites
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gdansk, 80-214
Biokinetica, Przychodnia Jozefow
Józefów, 05-410
Switzerland2 sites
Inselspital
Bern, 3010
Hôpitaux Universitaires de Genève
Geneva, 1211
About this study
Official title: A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.
- Being tested
- GDC-6036, Atezolizumab, Cetuximab, Bevacizumab, Erlotinib
- Keywords
- KRAS G12C, Non-Small Cell Lung Cancer, Colorectal Cancer, GDC-6036, Metastatic Solid Tumor, Atezolizumab, Bevacizumab, Cetuximab, Erlotinib, Inavolisib, GDC-1971, SHP2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-6036Drug
The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation).
AtezolizumabDrug
A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
CetuximabDrug
Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles.
BevacizumabDrug
A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
ErlotinibDrug
150 mg of erlotinib will be administered PO QD in 21 day cycles.
GDC-1971Drug
The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
InavolisibDrug
The starting dose of inavolisib will be determined from its single-agent dose escalation.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II) | Experimental | Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached.
Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II. Receives: Drug: GDC-6036 |
| Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II) | Experimental | Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab. Receives: Drug: GDC-6036; Drug: Atezolizumab |
| Arm C: GDC-6036 + Cetuximab (Stage I and Stage II) | Experimental | Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab. Receives: Drug: GDC-6036; Drug: Cetuximab |
| Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II) | Experimental | Participants with solid tumors will receive GDC-6036 in combination with bevacizumab. Receives: Drug: GDC-6036; Drug: Bevacizumab |
| Arm E: GDC-6036 + Erlotinib (Stage I and Stage II) | Experimental | Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib. Receives: Drug: GDC-6036; Drug: Erlotinib |
| Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II) | Experimental | Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I.
Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II. Receives: Drug: GDC-6036; Drug: GDC-1971 |
| Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) | Experimental | Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I.
Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II. Receives: Drug: GDC-6036; Drug: Inavolisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Measured: From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Measured: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
Secondary outcomes (12)
Plasma Concentrations of GDC-6036
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of Erlotinib
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of GDC-1971
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of Inavolisib
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Measured: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1
Measured: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Half-life [t1/2])
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between Tumor Pharmacodynamic Effects of GDC-6036
Measured: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start29 Jul 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449874
- Sponsor's protocol ID
- GO42144
- Other IDs
- 2020-000084-22, 2023-506311-18-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2020
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sacher AG, Miller WH Jr, Patel MR, Paz-Ares L, Santoro A, Ahn MJ, Dziadziuszko R, Freres P, Luo J, Bowyer S, Desai J, Markman B, De Miguel M, Deva S, Falcon A, Alonso G, Guedes JD, Kim SH, Krebs MG, Laurie SA, Massarelli E, Medina L, Prenen H, Amatu A, Van Dongen M, Choi Y, Hou X, Qi T, Lin MT, Koli K, Mayo MC, Yau KK, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL, Lorusso P; GO42144 Investigator Study group; GO42144 Investigator Study Group. Single-Agent Divarasib in Patients With KRAS G12C-Positive Non-Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study. J Clin Oncol. 2025 Oct 20;43(30):3249-3253. doi: 10.1200/JCO-25-00040. Epub 2025 Jul 9.
PubMed 40632992Desai J, Alonso G, Kim SH, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller WH Jr, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim TW, Moreno V, Ou SI, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel MR, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL; GO42144 Investigator and Study Group; Han SW. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):271-278. doi: 10.1038/s41591-023-02696-8. Epub 2023 Dec 5.
PubMed 38052910Sacher A, LoRusso P, Patel MR, Miller WH Jr, Garralda E, Forster MD, Santoro A, Falcon A, Kim TW, Paz-Ares L, Bowyer S, de Miguel M, Han SW, Krebs MG, Lee JS, Cheng ML, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Dharia NV, Schutzman JL, Desai J; GO42144 Investigator and Study Group. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. N Engl J Med. 2023 Aug 24;389(8):710-721. doi: 10.1056/NEJMoa2303810.
PubMed 37611121
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT04449874
- Acronym / sponsor ID
- GO42144
- Keywords
- KRAS G12C, Non-Small Cell Lung Cancer, Colorectal Cancer, GDC-6036, Metastatic Solid Tumor, Atezolizumab, Bevacizumab, Cetuximab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II) | Experimental | Drug: GDC-6036Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II. |
| Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II) | Experimental | Drug: GDC-6036, Drug: AtezolizumabParticipants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab. |
| Arm C: GDC-6036 + Cetuximab (Stage I and Stage II) | Experimental | Drug: GDC-6036, Drug: CetuximabParticipants with colorectal cancer will receive GDC-6036 in combination with cetuximab. |
| Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II) | Experimental | Drug: GDC-6036, Drug: BevacizumabParticipants with solid tumors will receive GDC-6036 in combination with bevacizumab. |
| Arm E: GDC-6036 + Erlotinib (Stage I and Stage II) | Experimental | Drug: GDC-6036, Drug: ErlotinibParticipants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib. |
| Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II) | Experimental | Drug: GDC-6036, Drug: GDC-1971Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II. |
| Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) | Experimental | Drug: GDC-6036, Drug: InavolisibParticipants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
- Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
- Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.
Key exclusion criteria (3 listed)
- Active brain metastases.
- Malabsorption or other condition that interferes with enteral absorption.
- Clinically significant cardiovascular dysfunction or liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-6036The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation). | Drug | Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II), Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II), Arm C: GDC-6036 + Cetuximab (Stage I and Stage II), Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II), Arm E: GDC-6036 + Erlotinib (Stage I and Stage II), Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II), Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) |
| AtezolizumabA 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles. | Drug | Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II) |
| CetuximabCetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles. | Drug | Arm C: GDC-6036 + Cetuximab (Stage I and Stage II) |
| BevacizumabA 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles. | Drug | Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II) |
| Erlotinib150 mg of erlotinib will be administered PO QD in 21 day cycles. | Drug | Arm E: GDC-6036 + Erlotinib (Stage I and Stage II) |
| GDC-1971The starting dose of GDC-1971 will be determined from its single-agent dose escalation. | Drug | Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II) |
| InavolisibThe starting dose of inavolisib will be determined from its single-agent dose escalation. | Drug | Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.
Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
12 secondary outcomes
Plasma Concentrations of GDC-6036
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of Erlotinib
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of GDC-1971
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of Inavolisib
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Time frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1
Time frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Half-life [t1/2])
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between Tumor Pharmacodynamic Effects of GDC-6036
Time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Derived from this study: PubMed 40632992Sacher AG, Miller WH Jr, Patel MR, Paz-Ares L, Santoro A, Ahn MJ, Dziadziuszko R, Freres P, Luo J, Bowyer S, Desai J, Markman B, De Miguel M, Deva S, Falcon A, Alonso G, Guedes JD, Kim SH, Krebs MG, Laurie SA, Massarelli E, Medina L, Prenen H, Amatu A, Van Dongen M, Choi Y, Hou X, Qi T, Lin MT, Koli K, Mayo MC, Yau KK, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL, Lorusso P; GO42144 Investigator Study group; GO42144 Investigator Study Group. Single-Agent Divarasib in Patients With KRAS G12C-Positive Non-Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study. J Clin Oncol. 2025 Oct 20;43(30):3249-3253. doi: 10.1200/JCO-25-00040. Epub 2025 Jul 9.
- Derived from this study: PubMed 38052910Desai J, Alonso G, Kim SH, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller WH Jr, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim TW, Moreno V, Ou SI, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel MR, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL; GO42144 Investigator and Study Group; Han SW. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):271-278. doi: 10.1038/s41591-023-02696-8. Epub 2023 Dec 5.
- Derived from this study: PubMed 37611121Sacher A, LoRusso P, Patel MR, Miller WH Jr, Garralda E, Forster MD, Santoro A, Falcon A, Kim TW, Paz-Ares L, Bowyer S, de Miguel M, Han SW, Krebs MG, Lee JS, Cheng ML, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Dharia NV, Schutzman JL, Desai J; GO42144 Investigator and Study Group. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. N Engl J Med. 2023 Aug 24;389(8):710-721. doi: 10.1056/NEJMoa2303810.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
63 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-6036, Atezolizumab and Cetuximab in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by Genentech, Inc. at 63 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Brazil, Spain, Italy, Australia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449874, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.